Bone Conduction Implants Recent Changes in Technology, Implant Options and Surgical Techniques Rebecca Cihocki AuD Clinical Trainer Our Company The Oticon Medical Company Part of William Demant Global leader in hearing health care Oticon Medical s core business is hearing implant solutions Bone anchored hearing systems Cochlear implant systems Headquarter in 3 sites Copenhagen, Denmark Close to WDH/Oticon headquarter Gothenburg, Sweden the cradle of bone anchored hearing Nice, France Technology park at Sophia Antipolis Focus on delivering lifelong patient outcomes based on innovative solutions and support History of Oticon Medical 2009 Launch of Ponto 2006 William Demant Bringing Sound Quality to acquires the project Bone Anchored 2007 Oticon Medical is established in Gothenburg. 2004 Project started by Patrik Westerkull 2009 CE and FDA approval. 2013 Ponto Plus and Ponto Streamer superior sound quality and wireless connectivity 2012 Launch of Wide Ponto Implant Industry s largest Bone 2011 First bone Implant contact. anchored digital power processor. 2013 Launch of Saphyr neo collection speech processor 2014 Entering partnership with Bo Håkansson on the BCI 2013 Entering in to the field of cochlear implants with the acquisition of *Not commercially Neurelec available in U.S. requires FDA Approval 2012 Our philosophy ** Not commercially a holistic approach available in the U.S. towards lifelong requires FDA Clearance 2012 First implant/ patient outcomes 2011 Freedom of abutment system choice with the Ponto designed for tissue System universal preservation interface. * ** 1
Osseointegration Osseointegration and Direct Bone Stimulation Living Bone Tissue (Osseo)Integrating with Titanium Osseointegration and Direct Bone Conduction Sound processor Abutment Implant/fixture The Basic Components of a Bone Anchored Hearing Device Direct Bone Conduction Stimulation Conductive / Mixed Indications 5 years and older >45 dbhl BC (Plus ) > 55 dbhl BC (PTA) (Plus Power).5K, 1K, 2K, and 3K Unilateral or bilateral Atresia / Microtia Chronic otitis media Cholesteatoma Otosclerosis Middle ear dysfunction/disease Prevents recurrence of otorrhea caused by earmolds External otitis 2
Direct Bone Conduction Stimulation Singled Sided Indications Deaf cochlea Direct Bone Conduction Stimulation Single sided deafness 5 years of age and older 20 dbhl AC PTA in better ear.5k, 1K, 2K, and 3K Acoustic neuroma Sudden deafness Trauma Meniere s Disease Cochlea One cochlea is picking up sound from both sides via bone conduction Osseointegration and Direct Bone Conduction Stimulation Sound processor coupling ISQ screw Abutment Ti Implant Surgical Considerations Abutment Design 3
Abutment Design and Surgical Technique First abutment with sharp angles forced full skin reduction Shaped the incision techniques for decades New abutment designs and lengths enable changes in the surgical technique OptiFit Abutment Design A range of abutment lengths Longer abutment lengths A design concept that optimally supports the skin Sharp edges could cause skin problem Chalmers University, Gothenburg, late 1970s Entific, Gothenburg, 1999 Oticon Medical Ponto system Gothenburg, 2009 Wide Ponto implant with 6 mm abutment Wide Ponto implant with 9 mm abutment Wide Ponto implant with 12 mm abutment Evolution in surgical techniques Evolution of Surgical Technique Dermatome Used since 2003 Hairless Skin flap Linear Incision Used since mid 90s Less invasive Minimal or no tissue removal Biopsy Punch Technique Used since 2009 Quick Surgery Minimal or no tissue removal 4
Tissue Preservation Surgery Surgical Video Improved patient outcomes Better cosmetics Less numbness and pain Quicker healing Minimal scar tissue Quicker surgery Fully reversible http://www.bing.com/videos/search?q=ponto+surgical+video&form=vire11# view=detail&mid=3e169372646127a64b223e169372646127a64b22 ** Hulcrantz, M. Outcome of the bone anchored hearing aid procedure without skin thinning: a prospective clinical trial Otology and Neurotology, 2011 Sep;32(7):1134 9),, Ponto Plus Sound Processors Accelerating Innovation Ponto Plus Up to 45 db BCHL Ponto Plus Power Up to 55 db BCHL 5
Durable, Reliable and Easy to Operate Ponto Plus User friendly push button for easy operating Metal spring coupling for durability and ease of use Everything you have come to know from so much more Ponto Water resistant nano coating New transducer design Hole for safety line IP 57 classification* Easy to access Volume control Tamper resistant battery door & Low battery warning system Improved Feedback Management Wireless capabilities With IP57 classification against moisture and dirt the highest in its class* * Please note, Ponto Plus is not waterproof. Users should always remove their sound processor while showering or bathing More Efficient and Powerful Transducer The Transducer Maximizing the magnetic field in the vibrator Same well proven reliability Same small size Approx. 60% higher output for the same power consumption 6
New Powerful Transducer = More of Everyday Sounds APowerful Sound Processor Sound levels in different everyday situations* Ponto Plus db 130 Sound Pressure Level (db SPL) Ponto Pro Percentiles 90th 75th Median 25th 10th 125 120 115 110 105 100 95 90 Ponto Plus Ponto Pro Series1 Plus Café/ restaurant Conversation in background noise Concert/ lecture/ theater Outdoors in traffic 85 80 100 1000 10000 *Based on recordings of users everyday situations and a typical Ponto user. The exact effect for a user will depend on the situation, hearing loss and choice of sound processor. Ref: Wagener et al. (2008) Output force level at 90dB SPL input at maximum gain. Ref: Oticon Medical tech sheet Power Across the Frequency Spectrum BAHS are inherently weak because the vibrator has to vibrate the whole skull More power means more audibility of everyday sounds Lower power means: Reduced audibility Poorer reproduction of own voice because of saturation issues Tinny sound quality Poorer result for patients with mixed hearing losses the 45 db HL fitting range may certainly be a stretch Poorer general acceptance by patients Ponto s Feedback Shield 7
Feedback in Hearing Aid Feedback in a Bone Anchored Device Acoustic feedback occurs when output is fed back to the input and re amplified. Preconditions for feedback to occur Gain must exceed the attenuation from the ear canal back to the microphone. Feedback path Sound Ponto Plus Two stage Feedback Management System Inium Feedback Shield Two stage Feedback Management System Two stage Feedback Management System At the clinic Feedback Manager At home Dynamic Feedback Cancellation Inium feedback shield At the clinic Feedback Manager At home Dynamic Feedback Cancellation Inium feedback shield People are different Situations are different Measurement Individual feedback limits inversion Frequency shift Feedback limit estimation The feedback shield limits feedback through a variety of advanced signal processing 8
Inium Feedback Shield: Advanced Signal Processing Components Phase inversion Subtract a copy of the feedback path Might cause artifacts if copy is wrong Most likely to happen in presence of tones Sound Processing Features Frequency shift Break the feedback path Make system less sensitive to tones 900Hz 10kHz: +10Hz Dynamic Frequency shift Ponto Plus Continuity Ponto Plus Continuity Same key features seen in Ponto processors: Tri state noise management Is engaged when detects background noise If detects only noise, reduces gain to maintain comfort Same key features seen in Ponto processors: Wind Noise reduction Main complaint of bone anchored users Forces processor into omni mode Noise management is activated across all 15 bands Speech Speech in Noise Noise 9
Ponto Bone Plus Continuity Same key features seen in Ponto processors: Speech Guard Preserves natural sound quality even in the presence of noise Pronto Plus Continuity Automatic Directionality 4 channels 3 modes omni, split, full Uses a directional mode more often New! Oticon Medical Streamer and ConnectLine App Ponto Streamer & ConnectLine 10
How do I get the ConnectLine App? The ConnectLine App can be downloaded free of charge on App Store and on Google Play. The Ponto Streamer The most connectivity opportunities in one system Ponto Streamer works straight out of the box No need for linking When installing the ConnectLine App on ipad, search for iphone apps in App Store. Cell Phone Tele Loop Music Computer Remote TV Phone Microphone FM Office Phone Apple Store is a service mark of Apple Inc. Google Play is a trademark of Google Inc. Ponto Streamer Buttons and Plugs Ponto Streamer Fitting On/off Battery Indicator ConnectLine phone and mobile ConnectLine microphone ConnectLine TV Power on/off Status Volume up/down Program shift Mute of hearing instruments microphones FM/A2DP/Jack/Telecoil (The Telecoil is built in) Ponto Streamer Works out of the box with any Ponto Plus. Pairs automatically to a Ponto within one meter If more than one Ponto user in room, use Genie Medical to link Streamer to just one Ponto Plus Battery charge (micro USB) FM plug Minijack 3.5 mm 11
Accessories FM OM Ponto Streamer ctr. Oticon Streamer Pro Oticon Medical Ponto Streamer Oticon Streamer Pro Open FM receivers which can be used together with Ponto Plus and Ponto Plus Power are: Oticon Amigo R2 & Oticon Amigo R1 Phonak MLxi universal receiver & Phonak Roger X universal receiver Widex universal receiver Comfort Audio DT 20 Doesn t work 45 ConnectLine and Accessories Transmission Range ConnectLine Tool End Fitting Screen Allows fine tuning of Ponto Streamer programs when connecting to devices TV: up to 30 meters (~100 ) Landline phone: up to 30 meters Microphone: up to 15 meters (~50 ) ConnectLine TV adapter ConnectLine Microphone ConnectLine Phone adapter The ConnectLine products are the same as for Oticon Streamer and hearing aids. 12
Instructional Videos Select Screen Demonstrates pairing of Ponto Streamer to various device Demonstrates installation of ConnectLine and adapters Considerations for pediatrics Implant Options 33696-00 Bone conduction Direct Drive vs Skin Drive systems There are two types of bone conduction devices: Direct Drive devices send vibrations via direct route to bone Skin Drive devices send vibrations through the skin to bone Direct Drive Bone Conduction Devices Direct contact Vibrator Bone Skin Drive Not direct contact Vibrator Bone Sounds are attenuated in skin drive solutions Physical facts with skin drive solutions: There is 10 20 db sound attenuation in mid to high frequency region 2 These devices have lower output in the mid to high frequency region. Difference in hearing threshold obtain with headband vs abutment Softband and magnet solutions provide similar performance 1 Implanted Vibrator Vibrator in Processor Vibrator hold by Headband or Softband Vibrator hold by Implanted magnet Ponto 33696-00 1) Briggs (2015) Clinical Performance of a New Magnetic Bone Conduction Hearing Implant System: Results from a Prospective, Multicenter, Clinical Investigation. Otol Neurotol. 2015 Jan 28. [Epub ahead of print] 33696-00 2) Verstraeten et al (2008) Comparison of the audiologic results obtained with the bone anchored hearing aid attached to the headband, the testband and to the snap abutment. Otology & Neurotology 30: 70 75 Magnetic 13
Comparing Sound Processor Bandwidths On the importance of bandwidth for children 130 120 Stelmakowich et al. (2001) Recognition of high frequency consonants Difference between speakers Force Output [db µn] 110 100 90 80 70 100 1000 10000 BP100 BAHA 4 Connect Frequency [Hz] The importance of /S/ 3 rd or 4 th most frequently occurring phoneme in the English language Makes a word plural Shows tense Shows possession Is that Mary? vs Is that Mary s? She put it on vs. she puts it on Keep Vs. Keeps Bring the Chair Vs. Bring the chairs The importance of high frequencies for children language development Clinical study Purpose: Determine learning rate for words presented with 4 khz and 9 khz bandwidths Method: Five nonsense words, paired with 5 novel pictures Outcome: Children need 3 times as many trials with limited bandwidth to learn new words as compared to the children who listen to extended bandwidth. 5 Sothnud Doztul Fosnush Stomun Homtul 33696-00 5) Pittman (2008) Short term word learning rate in children with normal hearing and children with hearing loss in limited and extended high frequency bandwidths. Journal of Speech, Language and Hearing Research. Vol5; 785 797 14
References Pittman AL. Short term word learning rate in children with normal hearing and children with hearing loss in limited and extended high frequency bandwidths. J Speech Lang Hear Res. Jun 2008;51:785 797. Stelmachowicz PG, Pittman AL, Hoover BM, Lewis DE. Effect of stimulus bandwidth on the perception of /s/ in normal and hearing impaired children and adults. J Acoust Soc Am. Oct 2001;110:2183 2190. Stelmachowicz PG, Pittman AL, Hoover BM, Lewis DE, Moeller MP. The importance of high frequency audibility in the speech and language development of children with hearing loss. Arch Otolaryngol Head Neck Surg. May 2004;130:556 562. Stelmachowicz PG, Lewis DE, Choi S, Hoover B. Effect of stimulus bandwidth on auditory skills in normal hearing and hearing impaired children. Ear Hear. Aug 2007;28:483 494. Moeller MP, Hoover B, Putman C, et al. Vocalizations of infants with hearing loss compared with infants with normal hearing: Part I phonetic development. Ear Hear. Sep 2007;28:605 627. Considerations for SSD 33696-00 Emphasis on HF amplification for SSD patients The goal is to lift the head shadow effect: The head shadow effect exists above 1500Hz, therefore only high frequencies need to be amplified Amplifying the low frequencies might disturb the natural hearing of the contralateral ear, leading to poorer hearing in background noise Summary Avoiding poor results for SSD patients Only direct drive solutions can amplify the needed frequencies. Fitting a skin drive solution to an SSD patient will most likely lead to very poor results. Thanks to the Feedback shield, Ponto can provide more high frequency amplification than any other bone conduction device, all without feedback. 33696-00 33696-00 15
Ponto Plus Accessories Color Options Ponto Plus Better hearing when you need it most More of the everyday sounds No compromises: Our strongest sound processor ever Less feedback and fewer artifacts with Inium feedback shield. Wireless communication possibilities with a user centric design All the existing, well known features of the Ponto sound processors Personalize the user s experience with slip ons and stickers Father and son.. Which one has the tatoo? 16